Development and Evaluation of a Web-Based Platform for Personalized Educational and Professional Assistance for Dementia Caregivers: Proposal for a Mixed Methods Study

Background Alzheimer disease (AD) and AD-related dementia are prevalent concerns for aging populations. With a growing older adult population living in the United States, the number of people living with dementia is expected to grow, posing significant challenges for informal caregivers. The mental and physical burdens associated with caregiving highlight the importance of developing novel and effective resources to support caregivers. However, technology solutions designed to address their needs often face low adoption rates due to usability issues and a lack of contextual relevance. This study focuses on developing a web-based platform providing financial and legal planning information and education for dementia caregivers and evaluating the platform’s usability and adoptability. Objective The goal of this project is to create a web-based platform that connects caregivers with personalized and easily accessible resources. This project involves industrial, academic, and community partners and focuses on two primary aims: (1) developing a digital platform using a Dementia Care Personalization Algorithm and assessing feasibility in a pilot group of caregivers, and (2) evaluating the acceptability and usability of the digital platform across different racial or ethnic populations. This work will aid in the development of technology-based interventions to reduce caregiver burden. Methods The phase I study follows an iterative Design Thinking approach, involving at least 25 dementia caregivers as a user feedback panel to assess the platform’s functionality, aesthetics, information, and overall quality using the adapted Mobile Application Rating Scale. Phase II is a usability study with 300 dementia caregivers in Texas (100 African American, 100 Hispanic or Latinx, and 100 non-Hispanic White). Participants will use the digital platform for about 4 weeks and evaluate its usefulness and ease of use through the Technology Acceptance Survey. Results The study received funding from the National Institute on Aging on September 3, 2021. Ethical approval for phase I was obtained from the Texas A&M University Institutional Review Board on December 8, 2021, with data collection starting on January 1, 2022, and concluding on May 31, 2022. Phase I results were published on September 5, 2023, and April 17, 2024, respectively. On June 21, 2023, ethical approval for human subjects for phase II was granted, and participant recruitment began on July 1, 2023. Conclusions Upon completing these aims, we expect to deliver a widely accessible digital platform tailored to assist dementia caregivers with financial and legal challenges by connecting them to personalized, contextually relevant information and resources in Texas. If successful, we plan to work with caregiving organizations to scale and sustain the platform, addressing the needs of the growing population living with dementia. International Registered Report Identifier (IRRID) DERR1-10.2196/64127


DESCRIPTION (provided by applicant):
There are currently about 5.8 million older adults living with Alzheimer's dementia, and the numbers are only expected to grow in the coming decades.The majority of care for persons living with dementia (PLWD) is provided by family members who lack formal training in caregiving and thus need education, information, and assistance.While an array of technology solutions for caregiving has been suggested to meet these needs, the adoption rate has been low, potentially due to poor usability (e.g., difficult to use) and lack of contextual relevancy.The long-term objective of this proposed research is to develop a technology-based solution that integrates web and mobile platforms to link dementia caregivers with personalized information and resources that are easily accessible by populations across the socioeconomic spectrum.The proposed study will focus on information and educational materials on financial management and legal planning.Such information will be helpful for caregivers experiencing difficulties due to their immediate caregiving responsibilities, as well as those transitioning in their roles and responsibilities as the PLWD's health condition progresses.This collaborative project, involving industrial, academic, and community partners, is oriented around two specific aims: (Phase 1 Specific Aim 1) Development of the digital platform based on a novel Dementia Care Personalization Algorithm and initial feasibility assessment.Framed around an interactive Design Thinking product design methodology, phase 1 consists of the iterative process: Build, Measure, and Learn.A pilot group of 25 dementia caregivers will be recruited to serve as a user feedback panel.Our milestone for moving to Phase 2 will be assurance of the feasibility of the digital platform assessed using metrics from the adapted Mobile Application Rating Scale (MARS) and Technology Adoption Model (TAM).(Phase 2 Specific Aim 2) Evaluation of the acceptance of the developed digital platform across racial/ethnic populations.Phase 2 is a prospective usability study to evaluate the acceptance of the proposed digital platform across three different racial/ethnic populations of dementia caregivers in Texas (N = 300; n = 100 African Americans, n = 100 Hispanic/Latinx, and n = 100 non-Hispanic Whites).The prospective feature of the study design will enable the enrolled participants to explore and use the developed digital platform for about 4 weeks to provide multiple assessments of the perceived usefulness, ease of use, and value.At the completion of the two specific aims, we expect to have developed a widely accessible digital platform tailored to assist dementia caregivers in navigating through financial and legal challenges by linking caregivers to personalized and contextually relevant information and resources in the Texas area.If successful, the proposed commercialization plan anticipates further deployment of the developed digital platform by working with professional caregiving organizations to scale and sustain the platform to meet the needs of the growing population of dementia caregivers.ZRG1 RPHB-W (15) FALOHUN, T PUBLIC HEALTH RELEVANCE: This is a three year fast-track SBIR application with phase I scheduled for 12 months and phase II for 24 months.The timeline in the research plan details tasks by phase (reflecting specific aims) and further by quarter.All milestones for phase 1 must be met before moving to phase 2. The project will develop the innovative digital platform incorporating a novel Dementia Care Personalization Algorithm and Educational Materials and Caregiver Resources library to assist caregivers of people living with dementia (PLWD).The product of this project will be commercially viable and poised for distribution across the US where it will help millions of caregivers of PLWD.

CRITIQUE 1
Significance: 2 Investigator(s): 2 Innovation: 2 Approach: 1 Environment: 5 Overall Impact: The applicant proposes fast track development of a cross-platform mobile phone and website app using a novel dementia care personalization algorithm (DCPA) to provide educational materials and a vetted resource library (EMCR) for professional assistance with legal, financial, and estate planning aspects of caregiving, tailored to diverse racial and ethnic family caregivers of those with AD/ADRD in the State of Texas.This is offered at no cost to the end user.Significance of the problem and appropriateness of the intervention are supported with past rigorous research and a funded study of a prototype.The commercialization plan is comprehensive.The innovation of the app is in the personalization and geolocation algorithms and its culturally sensitive design.The research strategy demonstrates scientific rigor with the Phase II approach based on the results of Phase I.The investigative team is strong in digital technology and design, dementia/caregiver issues, cultural issues, and curriculum development.Because the emphasis is on legal, financial, and estate planning for this population, the team would be strengthened with the addition of experts in elder law and finance.It is not clear in the application in what environment the application will be developed.There are minor concerns that there is no training manual/users guide and that users might be hesitant to divulge personal information to the app, negating its use.These do not dampen enthusiasm for the application.

Strengths
• Utility of the proposed product is supported with statistical data and past rigorous scientific research, including data on the use of technology by African American and Hispanic/Latinx caregivers.
• A prototype has received positive user feedback from 50 caregivers and stakeholders through funding from the National Science Foundation Innovation Corps site program.
• Product is proposed to support not only caregivers, but also serve as an access point to caregivers for professional organizations that support the app.
• Commercialization potential is supported with preliminary market data, evaluation of three existing products, and presentation of potential revenue streams.Software codes will be copyright protected.

Weaknesses
• Product development and testing in this Fast Track will include only caregiver resources in the State of Texas (but with the intent to expand to the entire US).
• Preliminary market analysis is based on senior housing and home care resources data only, not the broader network of professional caregiver assistance organizations.

Strengths
• PI Falohun has industry experience as a biomedical engineer and entrepreneurial experience as the founder of an interdisciplinary technology organization in his graduate program, and cofounder of his current startup company, Olera, to develop and commercialize digital solutions to medical problems.He and his company have no history of commercialization, but are supported by a team with those skills.
• Co-Investigator, DuBose, company VP, will receive MBA and MD degrees by 2022 and manages the commercialization strategies for the company under the mentorship of the Director of Technology Development at Texas A&M.
• PI and Co-PI have experience in their graduate programs managing multiple teams.
• The investigative team for Texas A&M brings strong credentials in research and publication.Dr.
Alonzo, PharmD, has R&D expertise in healthcare technology solutions for underserved populations, though none are specific to dementia.
• Dr. Ory, a former Program Director at the NIA and founding Director, Center for Population Health and Aging, School of Public Health, Texas A&M has an extensive history in dementia care and caregiver burden among diverse populations, and in establishing strategic partnerships and initiatives.She is PI on five current, variously funded studies related to technology support for persons with dementia and their caregivers.
• Dr. Pena-Purcell works extensively in developing evidence-based educational content for Latinx and African American minority health and in cultural competency -again, not AD/ADRD specific.
• Dr. Lee (Advisory Board) has translational research experience with technology-based interventions among caregivers of PWD.
• Dr. Opperman's (Advisory Board) has expertise in collaborating with small businesses to bring products to market.None are related to dementia.
• The Olera Advisory Board also includes expertise in taxes and law, and a safety net medical clinic director with direct experience supporting those with dementia and their caregivers.

Weaknesses
• To date, Olera has no history of bringing a product to market.
• The team would be strengthened with members or advisors with specific expertise in elder law and financial planning.

Innovation:
FALOHUN, T • Product's mobile app and website use logic-decision trees and geolocation to personalize both education and resource acquisition.
• Product employs user feedback allowing the algorithm to learn and adapt.
• Product has a dynamic interface that promotes active learning.
• App includes psycho-educational tools to support caregivers.
• Designed to be culturally and economically relevant for African American and Hispanic/Latinx families as well as for the non-Hispanic White population.
• Prototype interface is visually pleasant.
• Design is based, in part, on 50 prior prototype assessment interviews and data analysis conducted with dementia caregivers and key stakeholders.

Weaknesses
• There is no training guide for those who are technologically naïve, however it is suggested that future iterations may consider voice assistance technology.
• There is the potential that users will be reluctant to divulge personal data within the app.

Strengths
• Phase I tasks and milestones are clearly outlined using the iterative Build-Measure-Learn model with feedback from 25 caregivers using both qualitative data and the validated Mobile Application Rating Scale (MARS) with an identified significance level, to establish initial feasibility/usability.
• Inclusion/exclusion criteria for the research strategy in each Phase are clearly articulated to include adult children, spouses or other family members only.
• Study participant recruitment for Phase II includes Statewide and local agencies that have partnership histories with The Center for Population Health and Aging, uses various methods of outreach, and is based on local and national demographics.
• The Phase II research strategy builds on Phase I.The research protocol tests the product over a 4-week period with African American, Hispanic/Latinx, and non-Hispanic Whites.Protocol involves qualitative/quantitative measures to establish usability within each group.Power calculations and hypothesis testing are described.
• Potential problems and alternative approaches are discussed.
• Study timeline is reasonable for the tasks in each Phase.
• Major roles of each member of the investigative team are described.

Weaknesses
• Risks and benefits to human subjects participating in the research strategy for Phases I and II are not identified.

Environment:
Strengths FALOHUN, T • Olera's focus is on development and commercialization of innovative digital medical products with a current focus on dementia care.The company has a strong advisory board and close times to Texas A&M facilities and faculty.
• Resources and faculty at Texas A&M and the Center for Population Health and Aging have commitments in writing to support the project.

Weaknesses
• It is unclear where the digital application will be developed and how development software will be accessed.There is no budget line item for equipment and no description of a location.

Strengths
• None noted by reviewer

Weaknesses
• None noted by reviewer

Acceptable
• Proof of Concept (Phase I) and acceptance/usability (Phase II) are clearly articulated.

Protections for Human Subjects:
Acceptable Risks and Adequate Protections • Risks and protections need to be articulated.Though not specified in this application, it will clearly be required in the IRB applications.
Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): Not Applicable (No Clinical Trials) Inclusion Plans: • Sex/Gender: Distribution justified scientifically • Race/Ethnicity: Distribution justified scientifically Overall Impact: This is a novel approach to both aggregating but also customizing data on legal and financial decisions and resources for ADRD caregivers using a web-based platform, mobile app for on demand convenience and proprietary algorithm that customizes the recommendations.The collaborative support from Texas A&M University, including ADRD clinical experts and an existing Advisory Board of local community organizations for the platform, demonstrate viability and probably validity of the proposal.The Commercialization plan in Phase III is based solely on advertising and client referral revenues which will be based on achieving end-user goals in Phase II and partnership outreach in Phase I.

Strengths
• The personalization aspect of the proposal, especially for cultural, racial, socioeconomic and demographic filters, is novel in this space, particularly for legal and financial planning purposes.
• If Specific Aims are achieved in each Phase, the proposal provides a unique solution to existing challenges for ADRD caregivers and will create a more educated, empowered and less stressed caregiving population that has the downstream effect of potentially better patient-centered care and more financial stability for families.
• While not specifically called out as potential impact in the proposal, the information about the "Daily Caregiving Guide" customized to each user has strong potential for continued user engagement and psychosocial benefits of making caregivers feel part of a community rather than having the platform be just an information and education source.
• Specific milestones for each Phase are indicated with responsive assessment and analysis for moving the project forward to achieve Specific Aims.

Weaknesses
• The Commercialization Plan (Phase III) has potential based on advertising revenues models and customer referral programs.The vulnerability in the plan is that ad revenues will be based on users (who get free access), so fulfilling the proposed goals in Phase II is critical (4 million ZRG1 RPHB-W ( 15) FALOHUN, T users by 2024).Also, referral programs differ per organization with some only paying for secured placements instead of simple leads, others paying for warm leads versus cold leads.And, if the platform is truly comprehensive, then recommendations to caregivers will need to also include leads from organizations who do not pay for referrals -this would differentiate from the business models established by noted competitors such as A Place for Mom and Caring.com.
• While most of the educational material to be delivered via the platform is sourced to other expert organizations, it was not apparent in the budget ifs there is a line item for licensing such materials from certain groups (for instance the Alzheimer's Association has a licensing fee for all of its materials usage).

Strengths
• The PIs have complementary strengths that aid in the viability of the project.Particularly, Dr.
Ory's expertise and passion for ADRD caregiver support is matched by Mr. Falohun as the digital product and tech expert supplemented by Dr. Joy Alzono in the Pharmacy Dept.who has experience in deployment of software tools in patient populations.
• As well the collaboration with Texas A&M provides foundational support (including IP legal, regulatory and IRB guidelines) and access to an existing cohort of potential ADRD caregivers via health center and patient populations to participate in the validation stages.
• Eliciting participation with local community and government service organizations, including the Advisory Committee (AAAs, NAELA, Alzheimer's Association) in Phase I research and discovery is a key strength of the proposal.

Weaknesses
• To drive the user numbers needed to move to Commercialization in Phase III, strong marketing and community partner outreach is needed yet a marketing strategist is not indicated until this last Phase.This may impact some of the projected revenue goals in the first 12 months of the official launch in Phase III as the project ramps up on engagement.

Strengths
• The two biggest strengths of the proposal are the specialized algorithm (DCPA dementia caregiver personalization algorithm) to be developed to deliver the customization/personalization of information to individual caregivers; and the dedicated to delivering information in a culturally, racially, socioeconomically sensitive ways.By crossing the different sub-cohorts of caregivers (which also includes demographics, especially age of caregiver), this level of personalization appears to be novel and impactful in the ADRD caregiver support space.
• The proposal also has generalizability to deploy the concept to a broader cohort of caregivers beyond ADRD.Scalability will be predicated upon a similar approach used in Phase I for each local county/state to engage with local organizations and assess varying caregiver needs by geographics along with all the other data.This will be especially critical for rural and tribal areas where resources are more limited.
Weaknesses ZRG1 RPHB-W (15) FALOHUN, T • It is unclear in the proposal if the specialized algorithm is based on the more simple process through decision mode ("if this, then this") or if it will use machine learning or AI to continually customize the data for caregivers. • The Commercialization Plan has some potential vulnerabilities in terms of delivering projected revenue streams.The proposal indicates other potential referral clients beyond senior living, nursing homes and home care such as elder law attorneys, financial planners but does not indicate health plans, individual care managers, benefit managers and other potential sources.

Strengths
• The proposal is comprehensive in its outline of each Phase of the project leading to Commercialization in Phase III.Milestones and assessment, analysis are well-woven into the planning to achieve feasibility and proof of concept.Especially the transition from Phase I to Phase II indicates analysis of the concept based on Phase I findings.

Weaknesses
• It is unclear in the proposal how privacy of individual data will be secured, stored and protected.
• The proposal relies on content provided by external expert sources (e.g., Alzheimer's Association).However, it does not indicate how to develop original materials if there are gaps in the outsourced materials.
• While the empowerment of caregivers through education and information is solid in the proposal, what is less clear is how the caregivers will be advised on the next step for actionable planning (creation of legal documents, in-person financial planning).Referral sources are referenced as part of the Commercialization Plan but the question is will the platform only recommend paying referral clients (like the Caring.comor A Place for Mom competitors' model) or will recommendations be based on all sources and resources regardless of the revenue connection?

Strengths
• The academic medical center environment and institutional support will aid in the viability of the proposal and success of Phase I and II.
• The collaboration with community-based organizations (Alzheimer's Association and NAELA) and local government services (AAAs) also strengthens the success of the project as it moves through Phase I -III.
• The mission to deliver a diverse caregiver cohort (racially, culturally, demographically, socioeconomically) to drive personalization in a comprehensive way also makes the proposal a novel concept and greater engagement potential for Commercialization.

Weaknesses
• None for this area.Inclusion Plans: • Sex/Gender: • Race/Ethnicity: • For NIH-Defined Phase III trials, Plans for valid design and analysis: • Inclusion/Exclusion Based on Age: Vertebrate Animals: • None noted by reviewer Biohazards: • None noted by reviewer

Budget and Period of Support:
Recommend as Requested

CRITIQUE 3
Significance: 2 Investigator(s): 1 Innovation: 1 Approach: 2 Environment: 1 Overall Impact: This project aims to develop a technology-based solution that integrates web and mobile platforms to link dementia caregivers with personalized financial and legal planning information and resources that are easily accessible by populations across the socioeconomic spectrum.This technology would have a major impact on AD/ADRD caregivers by providing an easy-to-use, customized resource to aid financial and legal planning and reducing caregiver burden and time

•
None noted by reviewer Data and Safety Monitoring Plan (Applicable for Clinical Trials Only):

•
For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable